acetaminophen pm

Product NDC: 41163-515
11-digit product format: 411630515
Labeler code: 41163
Product ID: 41163-515_24b11c3b-9c19-ff00-e063-6394a90adbed
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen and Diphenhydramine Hydrochloride
Dosage form: TABLET, COATED
Route: ORAL
Labeler: United Natural Foods, Inc. dba UNFI
Application: M013
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2014-09-01
Substance: ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE
Active strength: 500; 25 mg/1; mg/1
Pharmacologic classes: Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	41163-515	41163-515-02	D	Discontinued by firm		2026-10-15
excluded package	package	41163-515	41163-515-14	D	Discontinued by firm		2026-10-15

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Package NDC, Snapshot table
Captured / source date	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	41163-515-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	41163-515-14	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	41163-515-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	41163-515-14	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	41163-515-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	41163-515-14	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	41163-515-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	41163-515-14	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	41163-515-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	41163-515-14	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	41163-515-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	41163-515-14	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	41163-515-02	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	41163-515-14	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	41163-515-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	41163-515-14	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	41163-515-02	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	41163-515-14	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	41163-515-02	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	41163-515-14	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	41163-515-14	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	41163-515-02	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	41163-515-14	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	41163-515-02	`557ba5c1ecfa…`	`9c80585c8c6e…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: acetaminophen pm
Brand name suffix: extra strength
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ACETAMINOPHEN	500 mg/1
DIPHENHYDRAMINE HYDROCHLORIDE	25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
362O9ITL9D	Internal UNII lookup
TC2D6JAD40	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1092189	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
f86a11af-6d3c-4638-870d-a663ddf49371	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
0e2e0f88-b076-afe1-4bdd-32bca4375bec	Product name	3	20250127
3e48c9c4-918d-5d23-2f0b-d2398b06be54	Product name	1	20140508
865c72dd-0d94-daac-f728-ddd4ded2a79e	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
41163-515-01	acetaminophen pmextra strength	1 in 1 CARTON	TABLET, COATED	1	10
41163-515-01	acetaminophen pmextra strength	24 in 1 BOTTLE, PLASTIC	TABLET, COATED	24	10
41163-515-02	acetaminophen pmextra strength	50 in 1 BOTTLE, PLASTIC	TABLET, COATED	50	10
41163-515-02	acetaminophen pmextra strength	1 in 1 CARTON	TABLET, COATED	1	10
41163-515-03	acetaminophen pmextra strength	100 in 1 BOTTLE, PLASTIC	TABLET, COATED	100	10
41163-515-03	acetaminophen pmextra strength	1 in 1 CARTON	TABLET, COATED	1	10
41163-515-14	acetaminophen pmextra strength	200 in 1 BOTTLE, PLASTIC	TABLET, COATED	200	10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
41163-515-01	EA - Each	41163-515	5c6c8447-ffdb-4a36-ad82-f857e36fb2a5	1	2016-10-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [SUPERVALUE INC.]	1
DIPHENHYDRAMINE HYDROCHLORIDE	ACTIVE INGREDIENT	TC2D6JAD40	ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [SUPERVALUE INC.]	1
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [SUPERVALUE INC.]	1
DIPHENHYDRAMINE	ACTIVE MOIETY	8GTS82S83M	ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [SUPERVALUE INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [SUPERVALUE INC.]	1
COPOVIDONE K25-31	INACTIVE INGREDIENT	D9C330MD8B	ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [SUPERVALUE INC.]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [SUPERVALUE INC.]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [SUPERVALUE INC.]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [SUPERVALUE INC.]	1
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [SUPERVALUE INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [SUPERVALUE INC.]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [SUPERVALUE INC.]	1
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [SUPERVALUE INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [SUPERVALUE INC.]	1
SODIUM STARCH GLYCOLATE TYPE A CORN	INACTIVE INGREDIENT	AG9B65PV6B	ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [SUPERVALUE INC.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [SUPERVALUE INC.]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [SUPERVALUE INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [SUPERVALUE INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
41163-515	ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [UNITED NATURAL FOODS, INC. DBA UNFI]	10	Current NDC, Legacy NDC, 7 package rows	20241019_f86a11af-6d3c-4638-870d-a663ddf49371.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 41 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
good sense pain relief	ACETAMINOPHEN	NuCare Pharmaceuticals,Inc.	3c1f505d-0319-a179-e063-6294a90a0b17	2025-08-11	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	PROSTAT FIRST AID	3bdb9d89-9000-69f9-e063-6294a90a0c97	2025-08-08	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	Prostat First Aid	3bdbea6a-3f11-9142-e063-6294a90a20ea	2025-08-08	Warnings	Exact identifier application number: M013
Aspi-Cor	ASPIRIN	L.N.K. International, Inc.	9f919a48-ffd8-49fa-b6fd-ec71cc12e64b	2025-08-08	Warnings	Exact identifier application number: M013
Aspirin Low Dose	ASPIRIN	A-S Medication Solutions	8575ef9d-2eae-412a-a252-82b03f4d5275	2025-08-08	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	A-S Medication Solutions	7a91b1df-8d6d-4205-9822-bc4d800555f7	2025-08-08	Warnings	Exact identifier application number: M013
M-PAP	ACETAMINOPHEN	Bryant Ranch Prepack	3d6bf733-800c-420a-a9ab-ae4a26134799	2025-08-08	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	A-S Medication Solutions	44b8c203-37c5-425e-9110-f7eb614f9c2d	2025-08-08	Warnings	Exact identifier application number: M013
Low Dose Aspirin	ASPIRIN	CHAIN DRUG MARKETING ASSOCIATION INC	c46688ec-e976-4f76-9265-645f59970ff5	2025-08-06	Warnings	Exact identifier application number: M013
Headache Relief Extra Strength	ACETAMINOPHEN, ASPIRIN, CAFFEINE	P & L Development, LLC	c54ad829-f2e8-4367-b439-af20b0ef8ad2	2025-08-06	Warnings	Exact identifier application number: M013
TYLENOL Regular Strength	ACETAMINOPHEN	Kenvue Brands LLC	398d8996-b522-a3cd-e063-6394a90ac2c8	2025-08-06	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	Marlex Pharmaceuticals Inc.	cc7013ea-cf30-6f59-e053-2a95a90a1148	2025-08-05	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	Prostat First Aid	3ba313db-bafe-1947-e063-6294a90a528c	2025-08-05	Warnings	Exact identifier application number: M013
MEDIQUE APAP acetaminophen	MEDIQUE APAP ACETAMINOPHEN	HF Acquisition Co LLC, DBA HealthFirst	3ba5c802-fe5a-e42a-e063-6394a90ae67e	2025-08-05	Warnings	Exact identifier application number: M013
meijer EXTRA STRENGTH Pain Relief PM CAPLET	ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE	Meijer, Inc.	376fed3b-7625-6379-e063-6394a90a188d	2025-08-05	Warnings	Exact identifier application number: M013
CAREONE INFANTS ACETAMINOPHEN	ACETAMINOPHEN	Retail Business Services, LLC	b8024ec2-97c6-4aa1-b1dd-894164f48811	2025-08-04	Warnings	Exact identifier application number: M013
Exaprin Plus	ASPIRIN, ACETAMINOPHEN, CAFFEINE	HART Health	8a9ca680-e6cf-4ee4-8a5f-bd6d7470b848	2025-08-04	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	Proficient Rx LP	2ef0757a-fe5f-47de-906a-a4d47a0d0534	2025-08-01	Warnings	Exact identifier application number: M013
Good Sense Pain Relief	ACETAMINOPHEN	Proficient Rx LP	b4cb4a62-9ef7-4185-8770-e9a806c2fb3f	2025-08-01	Warnings	Exact identifier application number: M013
Pain Relief	ACETAMINOPHEN	AAA Pharmaceutical, Inc.	36ad21a3-6229-e91b-e063-6394a90a7933	2025-07-29	Warnings	Exact identifier application number: M013

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
362O9ITL9D	ACETAMINOPHEN	103-90-2	ACETAMINOPHEN
TC2D6JAD40	DIPHENHYDRAMINE HYDROCHLORIDE	147-24-0	DIPHENHYDRAMINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1092189	acetaminophen 500 MG / diphenhydrAMINE HCl 25 MG Oral Tablet	PSN	f86a11af-6d3c-4638-870d-a663ddf49371	10
1092189	acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral Tablet	SCD	f86a11af-6d3c-4638-870d-a663ddf49371	10
1092189	APAP 500 MG / diphenhydramine hydrochloride 25 MG Oral Tablet	SY	f86a11af-6d3c-4638-870d-a663ddf49371	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
41163-515-01	41163051501	1 BOTTLE, PLASTIC in 1 CARTON (41163-515-01) / 24 TABLET, COATED in 1 BOTTLE, PLASTIC	2014-09-01	0000-00-00	No	No	Current
41163-515-02	41163051502	50 in 1 BOTTLE, PLASTIC					Historical
41163-515-03	41163051503	1 BOTTLE, PLASTIC in 1 CARTON (41163-515-03) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC	2014-09-01	0000-00-00	No	No	Current
41163-515-14	41163051514	200 in 1 BOTTLE, PLASTIC					Historical